Evaluation of unloading the heart in patients with cardiogenic shock treated with mechanical circulatory support devices

Not Applicable

• Conditions: Circulatory System; Cardiogenic shock

• Registration Number: ISRCTN82431978
• Lead Sponsor: King's College London

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2022-01-19
• Last Update Posted: 18 June 2024
• Study Completion: 2026-11-28

Recruitment & Eligibility

• Status: Ongoing
• Sex: All
• Target Recruitment: 36

Inclusion Criteria

1. Patients aged =18 years with cardiogenic shock of any aetiology
2. On veno-arterial extracorporeal membrane oxygenation (VA-ECMO) support or starting VA-ECMO post PCI
3. Undergoing clinically indicated cardiac catheterisation

Exclusion Criteria

1. Post-cardiotomy cardiogenic shock
2. Confirmed left ventricular thrombus on imaging
3. Age <18 years
4. Pregnancy or peripartum cardiomyopathy
5. Contraindication to either intra-aortic balloon pump (IABP) or percutaneous left ventricular assist device (pLVAD) insertion i.e. =moderate aortic regurgitation (AR), severe peripheral vascular disease (PVD) prohibiting insertion of either device
6. Mechanical aortic valve replacement (AVR)

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Coronary device flow reserve measured using a coronary guidewire post left ventricular (LV) unloading

Secondary Outcome Measures

Name	Time	Method
1. Early effect of LV unloading measured using an LV catheter post LV unloading<br>2. Minimal microvascular resistance calculated from pressure and flow measurements post LV unloading<br>3. Time to VA-ECMO decannulation (days) measured using patients' medical records<br>4. Days alive and off ICU (at 30 days post randomisation) measured using patients' medical records